Clinical utility study of confirms mdx for prostate cancer in a community urology practice.

Abstract

94 Background: There is an unmet need for methods to better identify patients most likely to benefit from repeat prostate biopsy after an initial negative biopsy. ConfirmMDx is a molecular test clinically validated for detection of prostate cancer (PCa) in tissue from PCa-negative biopsies. In this clinical utility study, we evaluated the impact of ConfirmMDx on the management of patients being considered for repeat prostate biopsy in a community urology practice. Methods: The study population consisted of 605 men with a prior PCa-negative prostate biopsy, who were counseled on the need to undergo repeat biopsy at a large community urology practice due to persistent elevated risk of PCa. All tissue cores from each PCa-negative patient were tested with the ConfirmMDx methylation-specific PCR test, and positive or negative ConfirmMDx results based on the presence or absence of GSTP1, APC or RASSF1 methylation in the biopsy tissue. ConfirmMDx results were provided to the physician for use in repeat biopsy decision-making. Medical record review was conducted at a minimum of nine months after ConfirmMDx results were reported. Results: Of the 605 subjects enrolled, 308 (51%) had a negative ConfirmMDx test result and 297 (49%) were positive. For the entire study population, average age was 64 (median 64, interquartile range 59 to 69), average serum PSA level 6.8 ng/mL (5.7, 4.3 to 8.1). The median follow-up for both Confirm positives and negatives was 10 months post-testing. Repeat biopsy rates for ConfirmMDx positive and negative men were 32.3% (96/297) and 5.8% (15/308), respectively (P < 0.001). For patients who received a biopsy during the follow-up period, the time between ConfirmMDx and repeat biopsy was shorter for ConfirmMDx positive men versus ConfirmMDx negatives (median 4 vs. 8 months, P = 0.007). Conclusions: In this utility study, ConfirmMDx had a significant impact on repeat prostate biopsy decision-making in a U.S. community urology setting. Repeat biopsy rates in ConfirmMDx positive men were six-fold higher than in ConfirmMDx negatives. These results reflect the clinical utility of ConfirmMDx for biopsy decision-making in real world clinical practice.

Recent advances and future perspectives in the therapeutics of prostate cancer

“…In a study done by Yonover et al in the United States, 605 men with an average age of 64 years, average PSA of 6.8 ng/mL, and a negative biopsy report underwent the ConfirmMDx test within ten months of the previous biopsy. They found that the test significantly impacted clinical decision making in rebiopsy settings [ 101 ].…”

Current and emerging tissue‐based molecular biomarkers for prostate cancer management: A narrative review

“…The repeat biopsy rate was 32.3% (96/297) for epigenetic assay‐negative men and 5.8% (15/308) for epigenetic assay‐positive men. The time to repeat biopsy was shorter for ConfirmMDx‐positive men (median: 4 months) compared with ConfirmMDx‐negative men (median: 8 months) [ 64 ] . These results highlight the ability of this test to not only influence the decision to proceed with a repeat biopsy but the time to biopsy as well.…”

Role of Nanotrace Element in Prostate Cancer an Update

“…Secernin-1 and vinculin is tissue based biomarker both will be validated by using 2D-DIGE combined with MS a powerful tool for diagnostic the protein level in prostate cancer [17]. ConfirmMDx test is a tissue based biopsy it is based on the presence and absence of GSTP1, APC or RASSF1 methylation in the biopsy tissue for the diagnosis purpose of prostate cancer [22]. Long non-coding RNAs has 200 nucleotide RNS transcript used for the diagnosis of prostate cancer.…”